Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
  • A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/32—Surgical cutting instruments
  • A61B17/3205—Excision instruments
  • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
  • A61B2017/00238—Type of minimally invasive operation
  • A61B2017/00243—Type of minimally invasive operation cardiac
  • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
  • A61B2017/00252—Making holes in the wall of the heart, e.g. laser Myocardial revascularization for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/0042—Surgical instruments, devices or methods with special provisions for gripping
  • A61B2017/00455—Orientation indicators, e.g. recess on the handle
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
  • A61B2017/22072—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other
  • A61B2017/22074—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel
  • A61B2017/22077—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel with a part piercing the tissue
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
  • A61B90/37—Surgical systems with images on a monitor during operation
  • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound
  • A61B2090/3782—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument
  • A61B2090/3784—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument both receiver and transmitter being in the instrument or receiver being also transmitter
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
  • A61B2090/3925—Markers, e.g. radio-opaque or breast lesions markers ultrasonic

Definitions

• the present invention relates generally to medical devices and methods, and more particularly to catheter devices and methods that are useable to form channels (e.g., penetration tracts) between vessels such as arteries and veins as well as between vessels and other anatomical structures, in furtherance of a therapeutic purpose such as bypassing an arterial blockage, delivering therapuetic agents, or performing other interventional procedures.
• channels e.g., penetration tracts
• channels e.g., bloodflow passageway(s)
• bloodflow passageway(s) e.g., bloodflow passageway(s)
• new procedures include novel percutaneous, transluminal techniques for bypassing obstructions in coronary or peripheral arteries through the use of the adjacent vein(s) as in situ bypass conduit(s), and other means of revascularizing oxygen starved tissues or delivering therapuetic substances to vessels, tissue and other organs.
• These procedures are fully described in United States Patent 5,830,222 and in United States Patent Applications 08/730,496, 09/048,147 and 09/048,147.
• a venous approach such as vein-to-artery wherein a tissue penetrating catheter is inserted into a vein and the desired arterio-venous passageway is initially formed by passing a tissue penetrating element (e.g., a flow of energy or an elongate penetration member) from a catheter, through the wall of the vein in which the catheter is positioned, and into the lumen of an adjacent artery.
• tissue penetrating element e.g., a flow of energy or an elongate penetration member
• some of these procedures may be performed by an artery-to- vein approach wherein the catheter is inserted into an artery and the desired arterio-venous passageway is initially formed by passing a tissue penetrating element (e.g., a flow of energy or elongate penetration member ) from the catheter, through the wall of the artery in which the catheter is positioned, and into the lumen of an adjacent vein.
• tissue penetrating element e.g., a flow of energy or elongate penetration member
• tissue penetrating catheters of the above-described type that are sized, configured and/or equipped differently for use in blood vessels of different sizes, shapes and in connection with different types of pathology.
• tissue penetrating catheters of the above- described type it is desirable for tissue penetrating catheters of the above- described type to be constructed and equipped for precise aiming and control of the tissue penetrating element as the tissue penetrating element passes from the catheter, through at least the wall of the blood vessel in which the catheter is located, and to the target location. Such aiming and control of the tissue penetrating element ensures that it will create the desired penetration tract at the intended location with minimal or no damage to surrounding tissues or other structures.
• the present invention provides methods and apparatus for performing the percutaneous in situ coronary arterio-venous bypass procedures generally described in United States Patent No. 5,830,222 and United States Patent Application Serial No. 08/730,327, and other procedures requiring the use of accurately placed catheter elements.
• A. Devices and System In accordance with the invention, there is provided a system for forming an initial penetration tract from the lumen of a blood vessel in which the catheter is positioned to a target location (such as another blood vessel, organ or myocardial tissue).
• This system generally comprises: a) a coronary sinus guide catheter which is insertable within the venous system of the body and into the coronary sinus of the heart; b) a tissue penetrating catheter which is advanceable to a position within a coronary vein, such tissue-penetrating catheter comprising i) a flexible catheter body, ii) a tissue penetrating element (e.g., a needle member, electrode orflow of energy) which is passable from the catheter body, through the wall of the coronary vein in which the catheter body is positioned and into the lumen of an adjacent coronary artery, or other targeted structure, iii) an imaging lumen through which an imaging catheter (e.g., an intravascular ultrasound imaging (IVUS) catheter) may be passed; and, c) a separate imaging catheter (e.g., an intravascular ultrasound (IVUS) catheter) that is advanceable through the imaging lumen of the tissue-penetrating catheter.
• a coronary sinus guide catheter which is insertable within the venous system
• this catheter system may include a subselective sheath and introducer.
• the subselective sheath comprises a flexible tubular sheath that has a proximal end, a distal end and a lumen extending therethrough.
• the introducer is insertable through the lumen of the sheath and has a tapered, non-traumatizing distal portion that protrudes out of and beyond the distal end of the sheath as well as a guidewire lumen extending longitudinally therethrough.
• the tapered, non-traumatic distal portion of the introducer serves to dilate the blood vessel lumens or openings through which the sheath is inserted, thereby facilitating advancement and positioning of the sheath at a desired location within the body.
• the introducer is extracted and various channel modifying catheters, connector delivery catheters and/or blocker delivery catheters may be advanced through the subselective sheath.
• the coronary sinus guide catheter may incorporate a hemostatic valve to prevent backflow or leakage of blood from the proximal end thereof.
• the coronary sinus guide catheter may include an introducer that is initially insertable through the guide catheter lumen.
• This introducer has a tapered, non-traumatizing distal portion that protrudes out of and beyond the distal end of the guide catheter, and a guidewire lumen extending longitudinally therethrough.
• the tapered, non-traumatizing distal portion of the introducer served to dilate the blood vessel lumens through which the guide catheter is inserted, thereby facilitating advancement and positioning of the coronary sinus guide catheter within the coronary venous sinus.
• the tissue-penetrating catheter may incorporate one or more of the following elements to facilitate precise aiming and control of the tissue-penetration element and the formation of the passageway at the desired location: a) Orientation Structure: An orientation structure may be positioned or formed on the distal end of the tissue penetrating catheter. This orientation structure has i) a hollow cavity or space formed therewithin in alignment with the catheter's imaging lumen and ii) a marker member positioned in direct alignment with the opening in the catheter through which the tissue penetrating element emerges (or otherwise in some known spacial relationship to the path that will be followed by the tissue penetrating element as it passes from the tissue penetrating catheter).
• the separate imaging catheter may be advanced through the tissue penetrating catheter's imaging lumen and into the receiving space of the orientation structure. Thereafter, the imaging catheter is useable to image the target location as well as the marker.
• the image of the marker provides a path indication that is indicative of the path that will be followed by the tissue penetrating element as it passes from the tissue penetrating catheter.
• the operator may then adjust the rotational orientation of the tissue penetrating catheter as necessary to cause the path indication to be aligned with or aimed at the target location, thereby indicating that when the tissue penetrating member is subsequently passed from the catheter body, it will advance into the target location and not to some other location.
• the imaging lumen, separate imaging catheter and orientation structure that are incorporated into the catheter system of this invention operate, in combination with each other, to facilitate precise rotational orientation of the tissue penetrating catheter and aiming of the tissue penetrating element before the tissue penetrating element is advanced, thereby ensuring that the tissue penetrating element will enter the desired target at the desired location.
• the orientation structure may comprise a plurality (e.g., three) of longitudinal struts, such longitudinal struts being disposed about a central space into which the IVUS catheter may be advanced.
• tissue-penetrating catheter may then be selectively rotated to aim the tissue penetrating element into the lumen of the artery or other target anatomical structure into which it is intended to pass.
• Soft Distal Tip Member The catheter may incorporate a soft distal tip member that is formed or mounted on the distal end of the tissue-penetrating catheter (e.g., on the distal aspect of the above-described orientation structure).
• Such soft tip member is preferably formed of material which is soft enough to avoid trauma to the walls of the blood vessels through which the tissue-penetrating catheter is passed.
• a lumen may extend longitudinally through the soft tip member, to allow the operator to selectively advance the IVUS catheter or other device beyond the distal end of the tissue-penetrating catheter when it is desired to image blood vessels or other structures located distal to the then-current position of the tissue-penetrating catheter or perform other diagnostic functions with said IVUS catheter or other device.
• the tissue penetrating catheter may incorporate a stabilizer to prevent or deter the tissue penetrating member from rotating or deviating from a predetermined acceptable penetration zone (APZ) (hereinafter sometimes referred to as the "stabilizer").
• AZA acceptable penetration zone
• stabilizer shall mean any structural or functional attributes of the catheter and/or tissue penetrating member that deter or prevent the tissue penetrating member from rotating or otherwise deviating from its intended path of advancement within a predetermined acceptable penetration zone (APZ).
• this stabilizer may comprise one or more of the following: i) a curved needle housing which mates (i.e.
• a laterally deployable needle guide member e.g., a balloon or rigid annular structure that is deployable from side of the
• tissue penetrating catheter adjacent to the outlet opening through which the tissue penetrating member passes to support and prevent unwanted lateral "play” or movement of the tissue penetrating member as it is advanced
• This outwardly deployable needle guide member is initially disposed in a "stowed” position wherein it does not protrude (or only minimally protrudes) from the catheter body, and is subsequently deployable to an
• tissue penetrating element e.g., needle member or
• This laterally deployable needle guide member may comprise a tubular cuff that has a lumen.
• the lumen of such tubular cuff may form, in combination with the catheter lumen in which the tissue penetrating element is positioned, a curvature that mates with or conforms to the preformed or intended curvature of the path of the tissue penetrating element as it passes from the catheter to the target location.
• the curvature of the laterally deployable needle guide member and/or catheter lumen may mate with or be the same as the curvature of the needle member.
• the tissue penetrating catheter may incorporate an apparatus that prevents or deters rotation of the tissue penetration member within the catheter body prior to its advancement out of the catheter. Such rotational locking of the tissue penetrating member while it is in its retracted position serves i) to maintain the desired rotational orientation of the needle member and ii) to enhance or couple the transfer of torque from the proximal end of the catheter to the distal end of the needle, without the addition of mass or cross-sectional dimension to the catheter body.
• the tissue penetrating device may comprise an elongate catheter body
• Said catheter body may incorporate reinforcement members such as a reinforcement braid member which imparts structural integrity/stability as well as enhancing the ability of the catheter body to transmit torque along its length. In addition, it may be important for said reinforcement member to maintain the longitudinal integrity of said catheter body, and to minimize any variability of the catheter components during operation in the body.
• PICAB Percutaneous In Situ Coronary Artery Bypass
• PICVA Percutaneous Coronary Venous Arterialization
• tissue penetrating element Pass the tissue penetrating element from the catheter, through the wall of the vein in which the catheter is positioned, and into the lumen of the artery, thereby forming an initial arterio-venous passageway distal to the arterial obstruction.
• the tissue penetrating element has a lumen extending longitudinally therethrough for passage of a guidewire from vessel to vessel.
• This preferred PICVA procedure generally comprises the steps of: 1. Introduce a coronary sinus guide catheter into the coronary sinus;
• the tissue penetrating element Pass the tissue penetrating element from the catheter, through the wall of the vein in which the catheter is positioned, and into the lumen of the artery, thereby forming an initial arterio-venous passageway distal to the arterial obstruction.
• the tissue penetrating element has a lumen extending longitudinally therethrough for passage of a guidewire from vessel to vessel.
• Figure 1 is a schematic showing of a human being having a tissue- penetrating catheter system of the present invention percutaneously inserted via a femoral entry site.
• Figure 1a is a broken, side elevational view of a first embodiment of a tissue-penetrating catheter of the present invention.
• Figure 1b is an enlarged view of the distal end of the catheter of Figure 1b.
• Figure 1 b' is a broken, side view of the catheter body construction of the catheter shaft of a tissue penetrating catheter of the present invention.
• Figure 1 b" is a detailed view of the braided construction of the catheter shaft of Figure 1 b'.
• Figure 1c is a cross sectional view through line 1c-1c of Figure 1a.
• Figure 1d is a cross sectional view through line 1d-1d of Figure 1a.
• Figure 1e is an enlarged, side elevational view of the needle housing/stabilizer assembly of the catheter of Figure 1a.
• Figure 1f is a cross sectional view through line 1f-1f of Figure 1e.
• Figure 1f is a cross sectional view through line 1f-1f of Figure 1f.
• Figure 2 is a representation of the intravascular ultrasound image that is obtained when the tissue-penetrating catheter of Figure 1 a is positioned within a coronary vein and properly oriented/aimed such that deployment of its tissue penetrating member will form a penetration tract (i.e., a passageway) from the coronary vein to an adjacent coronary artery.
• a penetration tract i.e., a passageway
• Figure 3 is a representation of the intravascular ultrasound image which is obtained when the tissue-penetrating catheter of Figure 1 a is positioned within coronary vein and improperly oriented/aimed such that deployment of its tissue penetrating member will not form a passageway from the coronary vein to the adjacent coronary artery.
• Figure 4 is a side elevational view of a subselective sheath and accompanying introducer that are useable in combination with the tissue- penetrating catheter of the present invention.
• Figure 4 a is a side elevational view of a dilator that is insertable through and useable in conjunction with the subselective sheath of Figure 4.
• Figure 5 is a partial longitudinal sectional view of the subselective sheath of Figure 4 having the dilator of Figure 4 a operatively inserted therein.
• Figure 5a is an enlarged, cross sectional view through line 5a-5a of Figure 5.
• Figure 6 is an enlarged, longitudinal sectional view of the distal portion of the subselective sheath of Figure 4.
• Figure 7 is a side elevational view of the tissue puncturing needle member of the tissue-penetrating catheter of Figure 1 a.
• Figures 8a is an enlarged, side elevational view of the distal end of the needle member of Figure 7.
• Figure 8b is an enlarged top view of the of the distal end of the needle member of Figure 7.
• Figures 9 & 9a show the hand piece/needle controller and distal end, respectively, of tissue-penetrating catheter of Figure 1 a with its tissue penetrating needle member in its retracted position.
• Figures 10 & 10a show the handpiece/needle controller and distal end, respectively, of tissue-penetrating catheter of Figure 1 a with its tissue penetrating needle member in its fully advanced position.
• Figure 10 d is a side elevational view of an optional rotation-inhibiting key insert and corresponding keyed needle member which may be incorporated into the tissue-penetrating catheters of the present invention to prevent the tissue-penetrating needle member from rotating relative to the body of the catheter.
• Figure 10 d' is a cross sectional view through line 10 d'-10 d' of
• Figure 10 d" is a cross sectional view through line 10 d"-10 d" of Figure 10 d.
• Figure 10 e is a side elevational view of an optional rotation-inhibiting oval insert and corresponding oval shaped needle member which may be incorporated into the tissue-penetrating catheters of the present invention to prevent the tissue-penetrating needle memberfrom rotating relative to the body of the catheter.
• Figure 10 e' is a cross sectional view through line 10 e'-10 e' of Figure 10 e.
• Figure 10 e" is a cross sectional view through line 10 e"-10 e" of Figure 10 e.
• Figure 10 f is a partial longitudinal sectional view of a tissue- penetrating catheter device of the present invention incorporating an optional locking collar apparatus for preventing the tissue penetrating needle memberfrom rotating relative to the catheter body when the needle member is in its retracted position.
• Figure 10 f ' is an enlarged view of region 10 f ' of Figure 10 f.
• Figure 10 g is a side elevational view of a tissue-penetrating catheter of the present invention having a laterally deployable needle stabilizer disposed in its "stowed' position.
• Figure 10 g' is a side elevational view of a tissue-penetrating catheter of the present invention having a laterally deployable needle stabilizer disposed in its "active" position.
• Figure 11 is a side elevational view of a coronary sinus guide catheter/introducer assembly of the present invention.
• Figure 11a is a cross-sectional view through line 11a-11a of Figure 11.
• Figure 11 b is an enlarged, longitudinal sectional view of the proximal end/hemostatic valve of the coronary sinus guide catheter shown in Figure 11.
• Figure 11c is broken, side elevational view of the introducer of the coronary sinus guide catheter/introducer assembly.
• Figure 12 is an enlarged, cross-sectional view through a coronary artery and adjacent coronary vein, showing the typical difference in diameter of the artery and vein, and delineating a preferred Acceptable penetration zone (APZ) wherein the arterio-venous bloodflow passageways of the present invention are formed.
• AZA Acceptable penetration zone
• Figures 13a-13x are schematic, step-by-step showings of a preferred method for performing a percutaneous, in situ coronary arterio-venous bypass (PICAB) procedure to bypass a blockage in the proximal Left
• PICAB percutaneous, in situ coronary arterio-venous bypass
• Anterior Descending coronary artery using a a vein-to-artery approach.
• Figures 14 a-14m are schematic, step-by-step showings of a preferred method for performing a percutaneous coronary venous arterialization (PICVA) procedure to provide retrograde arterial bloodflow through a coronary vein.
• PICVA percutaneous coronary venous arterialization
• a presently preferred catheter system of the present invention generally comprises i) a tissue-penetrating catheter component 10 ( Figures 1-3 and 7-10 a), ii) a subselective sheath/introducer component 100 ( Figures 4-6) and iii) a coronary sinus guide catheter/introducer component 200 ( Figures 11-11c).
• a tissue-penetrating catheter component 10 Figures 1-3 and 7-10 a
• a subselective sheath/introducer component 100 Figures 4-6
• iii) a coronary sinus guide catheter/introducer component 200 Figures 11-11c
• a tissue-penetrating catheter device 10 which is insertable into the vasculature of a mammalian patient and useable to form passageways (e.g., puncture tracts) between the blood vessel in which the distal end of the catheter device 10 is situated and another blood vessel or other anatomical structure.
• This catheter device 10 generally comprises an elongate, flexible catheter body 12 having a proximal portion 12 p of a first diameter D, and a distal portion 12 D of a second diameter D 2 which is smaller than the first diameter D ⁇
• the catheter body 12 has two (2) lumens 14, 16 which extend longitudinally therethrough.
• the first lumen 14 is sized and configured to permit a standard commercially available IVUS catheter (e.g., those available from Endosonics of Collinso Cordova, CA; CVIS of Natick, MA or Hewlett-Packard of Andover, MA) to be inserted therethrough and slidably disposed therewith.
• the second lumen 16 is sized and configured to house a tissue penetrating needle member 30
• An orientation structure 36 and tip member 38 are formed integrally with or mounted on the distal end of the catheter body 12, as shown in
• the orientation cage 36 comprises first 40, second 42 and third 44 strut members which extend longitudinally between the distal end of the catheter body 12 and the proximal end of the distal tip member 38.
• the first strut member 40 is in direct longitudinal alignment with a needle outlet opening 46 formed in the side of the catheter body 12 through which the tissue penetrating needle member 30 is advanced.
• the second and third strut members 42, 44 are located at equally spaced distances from the first strut member 40, while the distance between the second and third strut members 42,44 is less than the distance between either of those second and third strut members 42, 44 and the first strut member 40.
• Such disparate (e.g., unequal) radial spacing of these strut members 40, 44 and 46 allows the operator to easily identify and distinguish the first strut member 40 from the other two strut members 42, 44 by way of the image received from an IVUS catheter positioned within the orientation structure 36.
• the operator may selectively rotate the catheter body 12 until the first strut member 40 is directly aligned or juxtapositioned with the target blood vessel into which the needle member 30 is to be advanced.
• Figures 2 and 3 shows the IVUS image which is obtained when the tissue- penetrating catheter 10 is properly rotated such that the first strut member 40 is aligned with the target artery A and the needle member 30 will advance into such target artery A.
• Figure 3 shows another situation where the tissue-penetrating catheter 10 is not properly rotated, the first strut member 40 is not aligned with the target artery A and the needle member
• the disparate distancing of the strut members 40, 42, 44 is only one possible way of rendering the first strut member 40 distinguishable from the other two strut members 42, 44.
• the size or configuration of the first strut member could be different so as to produce a distinguishable ultrasound image or the material or surface characteristics of the first strut member 40 could be made different from the other two strut members 42, 44 such that the first strut member 40 would reflect more or less ultrasound than the other two strut members 42, 44 thus producing an ultrasound image which is distinguishable from the images produced by the other two strut members 42, 44.
• strut member may be required to provide a distinguishable element to aid catheter orientation, or alternatively two strut members may be positioned to delineate a zone within which the tissue penetrating member may be deployed, or other procedure conducted.
• the distal tip member 38 is preferably of blunt tipped configuration and is formed of smooth soft material (e.g., PEBAX having a durometer hardness of 35D) so as to minimize trauma to the vasculature as the tissue- penetrating catheter device 10 is advanced or otherwise manipulated about.
• a hollow lumen 39 may extend longitudinally through the tip member 38, in alignment with the first lumen 14 of the catheter body 12, such that an IVUS catheter or other device such as a guidewire may be advanced from the first lumen 14, through the orientation structure 36, through the distal tip lumen 38 and distally beyond the catheter device 10.
• the tissue penetrating element of the tissue penetrating catheter may comprise a sharp tipped needle 30 as shown in Figures 7, 8a and 8b.
• This needle 30 includes a proximal shaft 30p formed of stainless steel hypotubing and a resilient, curved distal portion 30d formed of a resilient material or, more preferably, a material such as NiTi alloy.
• a lumen 31 extends longitudinally through the proximal shaft 30p and the curved distal portion 30d.
• the particular radius of curvature of the curved distal portion 30d may be an important factor in determining the trajectory and path of the needle tip as it advances and the point at which the needle tip will stop when in its fully advanced position.
• the distal tip of the needle member 30 is preferably sharpened so as to easily penetrate through the walls of the blood vessels and any intervening tissue located therebetween.
• One preferred needle tip configuration is the lancet type bevel 36 shown in Figures 8a and 8b.
• This lancet type bevel comprises a first radial surface 36a and a second radial surface 36b.
• Such lancet type tip 36 provides excellent tissue-penetrability and retains its sharpness after multiple retractions into/advancements from the catheter.
• the controllability and aiming of the needle member 30 may be enhanced by constraining the needle member 30 such that it will remain in a preferred plane or acceptable penetration zone APZ as shown in Figure 12, as it is advanced from the catheter.
• any rotation of the needle member 30 prior to, during or after advancement of the needle member 30 can cause the distal end of the curved needle member to deviate from or move out of the intended plane or acceptable penetration zone APZ.
• the potential for such unwanted lateral movement of the distal end of the needle member 30 may be prevented or substantially limited by providing a stabilizer to prevent or substantially limit the amount of rotation that the needle member 30 may undergo relative to the catheter body 12 or to otherwise prevent or deter the needle memberfrom deviating from a predetermined acceptable acceptable penetration zone APZ ( Figure 12) as it is advanced from the catheter 10.
• APZ a predetermined acceptable acceptable penetration zone
• Figure 12 a predetermined acceptable acceptable penetration zone
• specific apparatus which may be incorporated into the catheter device 10 to prevent or deter rotation or lateral movement (i.e., "wagging” or “flopping") of the needle member 30 during or after its advancement from the catheter body 12, include: a) a curved needle housing 60 which has a curve at its distal end which mates with the preformed curvature of the needle member 30 to deter rotation (see Figures 9-1 Of); b) engaged surfaces 76, 77 formed on the needle member 30 and surrounding catheter body 12 to lock or deter rotation of the needle member 30, examples of such engaged surfaces 76, 77 including but not necessarily being limited to i) a tongue in groove or key in key-way arrangement (see Figures 10d-10d”) or ii) an oval to oval arrangement (see Figures 0e-10"), etc; c) a steering mechanism for causing the distal portion of the catheter body 12 to curve in the lateral direction in which the needle member 30 is intended to advance so as to cause the preformed curve of the needle member 30 to
• FIG. 1b-1f An example of a preferred curved needle housing 60 mountable within the needle lumen 16 is specifically shown in Figures 1b-1f.
• Such needle housing 60 comprises a curved, rigid tube.
• a tubular liner 61 may be disposed within, and may extend from either end of, the curved needle housing 60.
• Such tubular liner 61 may be formed of a three-layer composite wherein the inner layer is a lubricious polymer material (e.g., polytetrafluoroethylene (PTFE)), the middle layer is a structural polymer material (e.g., polyimide) and the outer layer is an adhesive material which will bond to the inner surface of the curved needle housing 60 and to the inner surface of the needle lumen 16 at either end of the housing 60 (e.g., polyurethane adhesive).
• PTFE polytetrafluoroethylene
• the middle layer is a structural polymer material (e.g., polyimide)
• the outer layer is an adhesive material which will bond to the inner surface of the curved needle housing 60 and to the inner surface of the needle lumen 16 at either end of the housing 60 (e.g., polyurethane adhesive).
• This prevention or deterrence from rotation of the needle member 60 allows the operator to control the orientation of the lancet type or other bevel formed in the needle tip, and also enhances the operator's ability to predict the precise position of the needle tip by eliminating or minimizing the uncontrolled side-to-side movement of the needle.
• a locator member 62 may be attached to the needle housing 60 and incorporated into the catheter body 12 as shown in Figures 1b, 1e, 1f, 1 f , 9a and 10a.
• This locator member 62 comprises a rigid disc 64 which is transversely positionable within the catheter body, having a first bore 66 and a second bore 68 extending longitudinally therethrough.
• a chamfered edge 69 is formed about the proximal, end of the first bore 66, as shown in Figures 1f and 1f.
• a rod or mandrel is inserted through the first bore 66 of the locator and into the first lumen 14 of the proximal catheter body portion 12 P and the curved needle housing 60 having a tubular liner 61 extending therethrough and protruding for either end, are inserted through the second bore 68 and into the second lumen 16 of the proximal catheter body portion 12 P .
• a distal plastic tube is advanced about the locator, a tubular polymer skin 73 is applied, and the composite is then heated to form the distal portion of the catheter body
• the needle member 30 and at least a portion of the second lumen 14 may incorporate engaged surfaces which are frictionally engaged to one another so as to prevent or deter rotation of the needle member 30 within the needle lumen 16.
• engaged surfaces 76, 77 include a key/key-way design shown in Figures 10d-10d" or an oval/oval design such as that depicted in Figures 10e-10e".
• the key/keyway method of preventing independent rotation of the needle member 30 may be effected by use of a key-way element 76 in combination with a keyed needle 30 key
• the key-way element 76 comprises a tubular member which has a key-way shaped lumen 77 with a key portion 79 extending longitudinally therethrough.
• the keyed needle 30 key comprises a hollow needle of the type described hereabove and shown in Figures 7-8b having a longitudinally extending rail or key member 33 formed upon a segment thereof.
• the key member 33 may be formed as a portion of the needle wall or may alternatively comprise a separate member, such as a section of hypotube, affixed to the side of the needle wall.
• the keyed needle 30 key is sized and configured to be advanced and retracted through the lumen 77 of the key-way housing, with the key member 31 being disposed within the key portion 79 of the lumen 77. In this manner the keyed needle member 30 key is longitudinally advanceable and retractable, but can not be rotated within the lumen 77 due to the engagement of the needle key member 31 with the key portion 79 of the lumen 77.
• the key- way element 76 is provided with a stabilizer 78 which is substantially the same as the needle housing stabilizer 62 described above and shown in Figures 1e-1f , and the key-way element 76/stabilizer 78 assembly may be installed and mounted within the catheter body at the time of manufacture in the same manner as described hereabove with respect to the needle housing 60/stabilizer 62 assembly shown in Figures 1e-1f .
• This key-way element 76/stabilizer 78 assembly is typically installed and mounted in the catheter body 12 proximal to the location of the needle housing 60/locator 62 assembly shown in Figures 1e-1f but near enough to the distal end of the catheter device 10 to prevent the portion of the needle adjacent its distal end from undergoing untoward rotation within the catheter body 12 during the catheter insertion procedure.
• This key-way element 76/stabilizer 78 assembly is typically installed and mounted in the catheter body 12 proximal to the location of the needle housing 60/locator 62 assembly shown in Figures 1e-1f but near enough to the distal end of the catheter device 10 to prevent the portion of the needle adjacent its distal end from undergoing untoward rotation within the catheter body 12 during the catheter insertion procedure.
• the device 10 may incorporate an oval shaped needle housing 76 ariad in combination with an oval shaped needle 30 ov
• the oval shaped needle housing 76 a)t comprises a tubular member positioned within the needle lumen 16 and having an oval shaped lumen 77 alt extending longitudinally therethrough.
• the oval shaped needle 30 ov comprises a hollow needle of the type described hereabove and shown in Figures 7-8b having an oval, ovoid or other non-round cross-sectional configuration.
• the oval shaped needle 30 ov is sized and configured to be advanced and retracted through the lumen 77 a réelle of the oval shaped needle housing 76 alt , but can not be rotated within the lumen 77 a réelle due to the engagement of the oval shaped needle member 30 ov with the oval shaped wall of the housing lumen 77 auß.
• the oval shaped needle housing 76 a century is provided with a locator 78 which is substantially the same as the needle housing locator 62 described above and shown in Figures 1e-1f , and the oval shaped needle housing 76 alt /locator 78 assembly may be installed and mounted within the catheter body 12 at the time of manufacture, in the same manner as described hereabove with respect to the needle housing 60/locator 62 assembly shown in Figures 1e-1f.
• This oval shaped needle housing 76 a chorus/locator 78 assembly will typically be installed and mounted in the catheter body 12 proximal to the location of the needle housing 60/locator
• Figures 10g and 10g' show an example of a needle guide member 500 which may be caused to project or extend laterally from the catheter body 12 in the area of the needle outlet aperture 46 to stabilize and guide the advancing needle member, thereby deterring lateral or side-to-side movement of the needle member 30 and further constraining the path which will be followed by the advancing needle.
• the deployment of such needle guide member 500 may also give rise to a lateral extension of the needle lumen 16 which mates with the preformed curve of the needle member 30 to prevent rotation of the needle member 30 in essentially the same manner as the curved needle housing 60 described above.
• the particular laterally deployable guide member 500 shown in Figures 10g and 10g' is an inflatable annular member that is connected to an inflation fluid lumen 502 that extends through the catheter body 12 to permit inflation fluid to be infused and withdrawn from the inflatable guide member 500.
• the guide member 500 When deflated (Figure 10g) the guide member 500 will nest within a depression or cut out region in the catheter's outer wall thereby assuming a configuration that is substantially flush with the outer surface 504 of the catheter body 12.
• the surface(s) of the inflatable guide member 500 that may be brushed against or contacted by the tip of the tissue penetrating member as it advances out of the outlet opening 46 may be armored or coated with a metal foil or other material that will resist puncture by the tip of the tissue penetrating member 30.
• the catheter body 12 may be provided with a mechanism for inducing a curve or bend in the region of the catheter body 12 proximal to the needle outlet aperture 46 to cause the portion of the needle lumen 16 proximal to the outlet aperture 46 to assume a curvature which mates with the curved shape to which the needle member 30 is biased, thereby deterring rotation of the needle member 30 within the catheter in the same manner described above with respect to the curved needle housing 60.
• the mechanism by which the catheter body 16 may be induced to curve may be any suitable catheter steering apparatus known in the art, such as an internal pull wire or spine member formed on shape memory alloy which is alternately transitionable between a straight configuration and a curved configuration.
• proximal shaft of the tissue-penetrating catheter 10 it is desirable for the proximal shaft of the tissue-penetrating catheter 10 to be endowed with enough structural integrity to transmit torque to the distal end of the catheter, as necessary for precise rotational orientation and aiming of the catheter device 10 before advancement of the needle member 30 therefrom. Also, in many applications, it is desirable for the needle member 30 to be maintained in a predetermined rotational orientation within the catheter body 12 prior to advancement of the needle member 30 from the catheter 10 (i.e., while the needle member 30 is still in its retracted state). In many applications, it is also desirable to minimize the diameter of the catheter body 12 to allow it to pass through small blood vessel lumens.
• FIGS. 10f-10f show a needle locking collar assembly 520, which comprises an enlarged region 522 formed within the needle lumen 16, wherein a first locking collar member 524 and second locking collar member 526 are located.
• the first locking collar member 524 is stationarily affixed to the catheter body 12 and has cavities or grooves 528 formed in the distal surface thereof and a central aperture through which the needle member 30 col may be advanced and retracted.
• the second locking collar member 526 is affixed to the needle member 30 ⁇
• the projections 530 are sized, located and configured to be received within the grooves 528 of the first collar member 524 when the needle member 30 ⁇ , is in its retracted position, thereby frictionally locking the needle member 30 ⁇ l to prevent its rotation relative to the catheter body 12.
• a handpiece/needle controller 15 is mounted on the proximal end of the Catheter body 12, and is useable to control the rotational orientation of the catheter body 12 and the advancement/retraction of the needle member 30. Also this handpiece/needle controller 15 has a proximal port 27 formed on its proximal end through which a small guidewire (e.g., a 0.0010- 0.016 inch diameter wire) may be advanced through the lumen 31 of the needle member 30, a first side port 21 through which a large guidewire (e.g., a 0.030-0.040 inch diameter wire) may be advanced through the first lumen 14 when that first lumen 14 is not occupied by an IVUS catheter, and a second side port 23 through which a flush solution may be infused into the catheter's second lumen 16 outside of the needle member 30 disposed therein.
• a small guidewire e.g., a 0.0010- 0.016 inch diameter wire
• a first side port 21 through which a large guidewire (e.
• the catheter body 12 includes a relatively stiff proximal section 12a, a medial section 12b, and a distal section 12cshown in Figs 1 A and 1 B.
• the catheter body exhibits varying flexibility and torque strength along its length, and may incorporate reinforcement members such as a reinforcement braid member which imparts structural integrity as well as enhancing the ability of the catheter body to transmit torque.
• a hand piece 15 is attached to the proximal end of the proximal section 12a, as shown. In the preferred embodiment the hand piece 15 and proximal section 12a are approximately 115cm in length.
• the medial section extends approximately 25cm terminating approximately 2cm from the distal section 12c.
• the proximal and medial sections of the catheter contain a braided component 50 as shown in Figs. 1 B' and 1B", encased in a polymer material (e.g. Pebax, nylon, polyurethane, polyester or PVC) extruded to form the inner lumen 50b and out jacket 50a of catheter body 12.
• a polymer material e.g. Pebax, nylon, polyurethane, polyester or PVC
• Fig. 1 B illustrates the braid angle A and pick count PC of the catheter braid 50.
• the "pick count" PC of the braid is, as is well known in the art, a function of the braid angle A (i.e., the greater the braid angle the more picks per inch).
• the torque transmission and stiffness of the braided section 50 is a function of the braid angle (i.e., a braid angle of 90 degrees provides maximum torque transfer and a braid angel of 0 degrees provides minimum torque transfer).
• Catheters used in the present invention that have exhibited this phenomenon have braid angles A that result in a pick count of 50 - 70 picks per inch.
• Figures 11-11c show a preferred coronary sinus guide catheter/introducer assembly 200, which comprises a) a flexible coronary sinus guide catheter 203 that has a curved distal portion 204, a proximal assembly 214 mounted on the proximal end of the flexible catheter body
• a reinforcement braid 212 such as a wire braid, is formed within a portion of the catheter body 203 but terminates approximately 2 to 5 centimeters from the distal end DE. In this manner, the reinforcement braid 212 will prevent kinking and improve torque strength of the proximal portion of the catheter body 203, and the curved portion thereof, up to a location at about 2 to 5 centimeters from its distal end DE.
• the proximal assembly comprises a rigid body 248 through which the lumen 202 extends, and upon which a proximal port 250 is formed to permit the guide introducer 213, subselective sheath 100 ( Figures 4-6), tissue- penetrating catheter device 10 ( Figures 1 and 9-10), or other catheters, guidewires and/or devices (e.g., blocker delivery catheter, channel connector delivery catheter, channel enlarging device, etc..) to be inserted through the lumen 202 of the coronary sinus guide catheter 200.
• a proximal port 250 is formed to permit the guide introducer 213, subselective sheath 100 ( Figures 4-6), tissue- penetrating catheter device 10 ( Figures 1 and 9-10), or other catheters, guidewires and/or devices (e.g., blocker delivery catheter, channel connector delivery catheter, channel enlarging device, etc..) to be inserted through the lumen 202 of the coronary sinus guide catheter 200.
• a hemostatic valve 244 such as a cross-cut resilient membrane, a slit-cut resilient membrane, or a flapper valve
• a side port 246 is formed on the proximal assembly 214 to permit preparation fluid to be infused or injected into or through the lumen
• a plurality of side apertures 210 are formed in the wall of the catheter body 203 near its distal end to allow pressure relief in the event that a radiographic contrast medium or other fluid is injected.
• a preferred subselective sheath 100 of the present invention comprises a flexible sheath body 102 having a proximal hub 104 and a lumen 106 extending longitudinally therethrough.
• a reinforcement braid 108 is formed within the catheter body 102 to prevent kinking and improve torque strength. Such reinforcement braid terminates distally at 0.1-1.0 centimeter from the distal end of the catheter body 102.
• a gradual taper 110 is formed about the distal end of the sheath body's outer surface to such that the sheath 100 will taper to a flush transition with the distally protruding portion 111 d of its introducer 111.
• the lumen 202 has an inner diameter D1 which is substantially the same as the outer diameter of the introducer 111 that is initially inserted through the lumen 106.
• the introducer 111 has a guidewire lumen 109 that extends longitudinally therethrough to permit the subselective sheath/introducer assembly to be advanced over a previously inserted guidewire GW (e.g., a 0.035 inch guidewire).
• the outer diameter of the sheath 100 is sized to be advanced and retracted through the lumen 202 of the coronary sinus guide catheter 200 ( Figures 11 -11 b). The preferred method of using this subselective sheath 100 and introducer 111 are described in detail herebelow with respect to the methods of the present invention.
• the present invention also includes methods for using this catheter system described hereabove (or any other catheter system or devices that may be suitable to carry out the desired purpose), in conjunction with other apparatus such as guidewires, channel enlarging catheters/devices, channel connecting catheters/devices and vessel blocking catheters/devices to perform percutaneous, in situ coronary arterio-venous bypass procedures by way of a vein-to-artery approach, such method being fully described herebelow and shown in step-by-step fashion in Figures 13a-13x and 14a- 14m.
• 11 b is useable in conjunction with a fluoroscope, an IVUS imaging catheter, a coronary sinus access catheter (e.g., a standard angiographic catheter), a channel-enlarging catheter device, lumen-blocking device(s), a 0.035 inch diameter guidewire, and one or more 0.014 inch diameter guidewire(s) to perform various revascularization procedures including, as described in detail herebelow, a Percutaneous In Situ Coronary Artery Bypass (PICAB) procedure as well as a Percutaneous In Situ Coronary Venous Arterialization (PICVA) procedure.
• PICAB Percutaneous In Situ Coronary Artery Bypass
• PICVA Percutaneous In Situ Coronary Venous Arterialization
• catheter system of the present invention may also be useable to perform various other procedures such as directed drug delivery procedures of the type described in co-pending United States Patent Application SN 09/048,147 and other revascularization procedures.
• FIGS 13a-13x show, in step-by-step fashion, an example of a PICAB procedure wherein the catheter system 10 of the present invention is used for the purpose of bypassing a blockage located in the proximal portion of the Anterior Descending Coronary Artery (LAD) of a human patient.
• a coronary sinus access catheter e.g., a standard angiographic catheter such as the modified Simmons-type angiographic catheter available from Cook Cardiology, Bloomington, Indiana
• the PICAB procedure proceeds as follows:
• First Step Coronary Sinus Access / Introduction of First Guidewire: As shown in Figure 13a, an arterial blockage AB to be bypassed is located in the left anterior descending coronary artery (LAD).
• the coronary sinus access catheter 500 is advanced into the coronary sinus CS, as shown in Figure 13b, to assist in the placement of a 0.035 inch diameter guidewire G ⁇ N into the great cardiac vein (GCV) and anterior interventricular vein (AlV).
• This guidewire GW can be pre-loaded in the lumen of the coronary sinus access catheter 500 or can be advanced through the lumen of the coronary sinus access catheter 500 after it has been positioned inj the coronary sinus, as a separate step. Thereafter, the coronary sinus access catheter 500 is removed, leaving the 0.035 inch guidewire GW t in place.
• Second Step Introducton of Coronary Sinus Guide Catheter / AlV
• the coronary sinus guide catheter 200 with introducer sheath 100 disposed within or through its lumen 202 is advanced over the 0.035 inch guidewire GW 1 until the tip of the coronary sinus guide catheter 200 is past the "mouth" of the coronary sinus.
• the introducer sheath 100 is then removed, leaving the coronary sinus guide catheter 200 in place, in the manner shown in Figure 13d.
• the tissue-penetrating catheter 10 is then inserted over the pre-positioned 0.035 inch guidewire GW t , through the lumen 202 of the coronary sinus guide catheter 200, and is advanced using fluoroscopy to a position distal to the arterial blockage AB being bypassed.
• the 0.035 inch guidewire GW 1 is then extracted and removed from the first lumen 14 of the tissue-penetrating catheter 10 and an IVUS imaging catheter (not shown) is then advanced through that first lumen 14 until the
• IVUS transducer resides within the hollow interior space of the orientation structure 36.
• the IVUS catheter is then used to receive a 360 degree ultrasound image from a vantage point within the interior space of the orientation structure 36.
• Such image enables the operator to see both the resident vessel (the AlV) and the target vessel (the LAD), as well as the reflections or artifacts from the three strut members 40, 42 &44 of the orientation structure 36.
• the reflections or artifacts produced by the strut members will form a generally "Y" shaped image as illustrated in Figures 2 and 3 of this patent application.
• the reflection 40 Ref produced by the first strut member 40 is clearly distinguishable from the reflections 42 Ref , 44 Ref produced by the second and third strut members 42, 43, and provides an indication of the particular direction in which the needle member 30 will travel when advanced from the needle outlet opening 46 in the side of the catheter body 12.
• the operator will rotate the tissue-penetrating catheter 10 until such first strut member reflection 40 Ref observed on the IVUS image does extend directly toward or into the lumen of the LAD (as illustrated in Figure 2). This will ensure that the needle member 30 is properly aimed to enter the LAD when advanced.
• a 0.014 inch diameter guidewire GW 2 is inserted through the proximal port 27 of the tissue-penetrating catheter handpiece/needle controller 15 and advanced through the lumen 31 of the needle member 30 into the target vessel (the LAD), as shown in Figure 14h.
• the needle member 30 is withdrawn to its retracted position, leaving the 0.014 inch. diameter guidewire GW 2 extending through the initially formed interstitial passageway into the target vessel (the LAD) as shown in Figure 14h.
• the tissue-penetrating catheter 10 is withdrawn and removed, leaving the 0.014 inch guidewire in place (i.e., extending through the newly formed arterio-venous penetration tract PT).
• the subselective sheath 100 with its introducer 111 inserted therethrough is advanced through the coronary sinus guide 200 over the large guide wire GW,. Thereafter, the introducer
• embolic blocker members BM are introduced into the proximal end of the subselective sheath, pushed through the lumen of the subselective sheath 100 using a pusher rod (not shown) and expelled into the lumen of the coronary vein (the AlV) where such embolic blocker(s) expand and engage the wall of the vein to cause substantial occlusion and blockage of bloodflw through the vein ath that location.
• a pusher rod not shown
• the AlV coronary vein
• the 0.035 inch diameter guidewire GW is reinserted through the subselective sheath 100 and the subselective sheath 100 is then withdrawn and removed as shown in Figure 13k.
• the tissue-penetrating catheter 10 is then once again advanced over the 0.035 inch diameter guidewire GW 1 t under fluoroscopy, to a position that is proximal to the previously-formed distal penetration tract PT.
• the above-described fourth step is then repeated to form another initial arterio-venous penetration tract PT proximal to the blockage, and to pass a second 0.014 inch guidewire GW 3 through that second arterio-venous penetration tract PT.
• the tissue-penetrating catheter 10 is then withdrawn and removed, leaving both 0.014 inch guidewires GW, and GW 3 in place, in the manner shown in Figure 13n.
• Application 09/056,589 is advanced over the 0.014 inch guidewire GW 2 which extends through the distal arterio-venous penetration tract PT, thereby the dilating or enlarging that tract to form an arterio-venous bloodflow passageway PW.
• This step of the procedure provides control over the diameter or size of the arterio-venous bloodflow passageways PW and helps to ensure that the passageways PW will remain patent and functional following completion of the procedure.
• the channel enlarging catheter device CEC is withdrawn and removed along with the subselective sheath 100, leaving both 0.014 inch guidewires GW,and GW 3 in place, in the manner shown in Figure 13p.
• a connection device may be deployed in the passageway PW.
• the subselective sheath 100 and its introducer 111 are then advanced over the distal channel guidewire GW2 to a position where the distal end of the subselective sheath 100 is in the AlV immediately adjuacent the distal bloodflow passageway PW. Thereafter, the introducer 111 is removed and a connector device delivery catheter CDC, of the type described in United States Patent Application Serial No.
• 08/970,694 is advanced over through the subselective sheath 100 and over the 0.014 inch guidewire GW 2 which extends through the distal arterio-venous passageway PW, to implant a connector device CD within that passageway PW.
• the connector delivery catheter device CDC is then removed, along with the subselective sheath 100 and the distal 0.014 inch guidewire GW 2 that had extended through the distal arterio-venous passageway PW, leaving the distal connector device CD in place within the distal arterio-venous passageway PW in the manner shown in Figure 13s.
• the subselective sheath 100 and its introducer 111 are then advanced over the distal channel guidewire GW2 to a position where the distal end of the subselective sheath 100 is in the
• the channel enlarging catheter device CEC is withdrawn and removed leaving the subselective sheath 100 and proximal 0.014 inch guidewire GW 3 in place, as shown in Figure 13u.
• a connection device may be deployed in the passageway PW.
• a connector device delivery catheter CDC of the type described in United States Patent Application
• Serial No. 08/970,694 is then advanced through the subselective sheath 100 and over the 0.014 inch guidewire GW 3 which extends through the proximal arterio-venous passageway PW, to implant a connector device CD within that passageway PW.
• the connector delivery catheter device is then removed, and the subselective sheath 100 and 0.014 inch guidewire GW 3 are then retracted to a position within the Great Cardiac Vein GCV, proximal to the proximal passageway PW, as shown in Figure 13w, leaving the proximal connector device CD in place within the proximal arterio-venous passageway.
• the above-described fifth step is then repeated to implant a second blocker device BD within the lumen of the Great Cardiac Vein (GCV), proximal to the proximal arterio-venous passageway PW.
• GCV Great Cardiac Vein
• CX Circumflex Artery
• CX Circumflex Artery
• GCV Great Cardiac Vein GCV
• Anterior Interventricular Vein in the retrograde direction
• LAD Left Anterior Descending coronary artery LAD
• Figures 14a-14m show, in step-by-step fashion, an example of a PICVA procedure wherein the catheter system 10 of the present invention is used for the purpose causing arterial blood to be rerouted into the Anterior Interventricular Vein and caused to subsequently flow through the AlV in retrograde fashion (i.e., in a direction opposite normal venous return) thereby bypassing an extensive blockage within the patient's Anterior Descending Coronary Artery (LAD) and perfusing the region of myocardium that had been rendered ischemic due to the extensive blockage in the LAD.
• LAD Anterior Descending Coronary Artery
• a coronary sinus access catheter e.g., a standard angiographic catheter such as the modified Simmons-type angiographic catheter available from Cook Cardiology, Bloomington, Indiana
• a coronary sinus access catheter is initially inserted through a femoral vein or external jugular vein approach, using standard percutaneous catheter insertion technique.
• the PICAB procedure proceeds as follows:
• First Step Coronary Sinus Access / Introduction of First Guidewire: As shown in Figure 14a, an extensive arterial blockage AB extends though substantially the entire length of the left anterior descending coronary artery (LAD), thereby rendering this patient an unlikely candidate for the above-described PICAB procedure because no patent distal portion of the LAD remains available to receive the bypass arterial bloodflow. It is appreciated that in cases where the disease AB does not extend into the proximal portion of the LAD, a connection may be established between the LAD and the AlV proximal to the blockage, but there would be no opportunity to make a distal connection as required by the PICAB procedure.
• LAD left anterior descending coronary artery
• a coronary sinus access catheter 500 is advanced into the coronary sinus CS to assist in the placement of a 0.035 inch diameter guidewire GW, into the great cardiac vein (GCV).
• This guidewire GW can be pre-loaded in the lumen of the coronary sinus access catheter 500 or can be advanced through the lumen of the coronary sinus access catheter 500 after it has been positioned in the coronary sinus, as a separate step. Thereafter, the coronary sinus access catheter 500 is removed, leaving the 0.035 inch guidewire GW, in place.
• the tissue-penetrating catheter 10 is then inserted over the pre-positioned 0.035 inch guidewire GW, , through the lumen 202 of the coronary sinus guide catheter 200, and is advanced using fluoroscopy to a position proximal to the arterial blockage AB being bypassed.
• the 0.035 inch guidewire GW is then extracted and removed from the first lumen 14 of the tissue-penetrating catheter 10 and an IVUS imaging catheter (not shown) is then advanced through that first lumen 14 until the IVUS transducer resides within the imaging catheter-receiving space of the orientation structure 36.
• the IVUS catheter is then used to receive a 360 degree ultrasound image from a vantage point within the interior space of the orientation structure 36.
• a 360 degree ultrasound image enables the operator to see both the resident vessel (the GCV) and the target vessel (the CX), as well as the reflections or artifacts from the three strut members
• the reflections or artifacts produced by the strut members will form a generally "Y" shaped image as illustrated in Figures 2 and 3 of this patent application.
• the reflection 40 Ref produced by the first strut member 40 is clearly distinguishable from the reflections 42 Ref , 44 Ref produced by the second and third strut members 42, 43, and provides an indication of the particular direction in which the needle member 30 will travel when advanced from the needle outlet opening 46 in the side of the catheter body 12.
• the operator will rotate the tissue-penetrating catheter 10 until such first strut member reflection 40 R ⁇ f observed on the IVUS image does extend directly toward or into the lumen of the CX (as illustrated in Figure 2). This will ensure that the needle member 30 is properly aimed to enter the CX when advanced.
• the tissue penetrating needle member 30 is then advanced in the distal direction to its extended position such that it punctures through the wall of the resident vessel (the GCV), through any tissue which may exist between the resident vessel (the GCV) and the target vessel (the CX) and into the lumen of the target vessel (the CX) at a location downstream of the arterial blockage AB.
• This maneuver results in the formation of an initial arterio-venous penetration tract PT.
• a 0.014 inch diameter guidewire GW 2 is inserted through the proximal port 27 of the tissue-penetrating catheter handpiece/needle controller 15 and advanced through the lumen 31 of the needle member 30 into the target vessel (the CX), as shown in Figure 14h.
• the subselective sheath 100 and its introducer 111 are advanced through the guide catheter 203, over the second guidewire GW2 to a locationojn where the distal end of the subselective sheath 100 is within the AlV immediately adjacent the distal penetration tract PT. Thereafter, the intoducer 111 is withdrawn and a channel enlarging catheter device CEC, of the type described in United States Patent Application 09/056,589, is advanced over the 0.014 inch guidewire GW 2 which extends through the arterio-venous penetration tract PT, thereby the dilating or enlarging that tract to form an arterio-venous bloodflow passageway PW.
• CEC channel enlarging catheter device
• This step of the procedure provides control over the diameter or size of the arterio-venous bloodflow passageways PW and helps to ensure that the passageways PW will remain patent and functional following completion of the procedure.
• the channel enlarging catheter device CEC is withdrawn and removed, leaving the subselective sheath 100 and second guidewire GW 2 in place.
• a connector device delivery catheter CDC of the type described in United States Patent Application Serial No. 08/970,694, is advanced over through the subselective sheath 100 and over the 0.014 inch guidewire GW 2 which extends through the arterio-venous passageway PW, to implant a connector device CD within that passageway PW.
• the connector delivery catheter device CDC is then removed, and the subselective sheath 100 and the 0.014 inch guidewire GW 2 that had extended through the distal arterio- venous passageway PW are then retracted to a position proximal to the passageway PW..
• the guidewire GW 2 is then removed and one or more embolic blocker members BM are introduced into the proximal end of the subselective sheath 100, pushed through the lumen of the subselective sheath 100 using a pusher rod (not shown) and expelled into the lumen of the Great Cardiac Vein (GCV) proximal to the bloodflow passageway PW where such embolic blocker(s) expand and engage the wall of the vein to cause substantial occlusion and blockage of bloodflow through the vein at that location.
• GCV Great Cardiac Vein
• the 0.035 inch diameter guidewire GW is then removed, and an embolic blocker member BM is inserted into the proximal end of the subselective sheath.
• a push rod is then advanced through the lumen of the blocker delivery catheter to push the embolic blocker member BM out of the distal end of the subselective sheathand into its desired position within the lumen of the coronary vein (the GCV).
• this blocker deployment step may be performed at this point in the procedure, or alternatively may be delayed until a later time in the procedure.

Landscapes

• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Surgery (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Animal Behavior & Ethology (AREA)
• Molecular Biology (AREA)
• Medical Informatics (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Vascular Medicine (AREA)
• Orthopedic Medicine & Surgery (AREA)
• Biophysics (AREA)
• Pulmonology (AREA)
• Anesthesiology (AREA)
• Hematology (AREA)
• Ultra Sonic Daignosis Equipment (AREA)
• Media Introduction/Drainage Providing Device (AREA)
• Surgical Instruments (AREA)
• Materials For Medical Uses (AREA)

Applications Claiming Priority (3)

Publications (3)

Family

ID=22155874

Family Applications (3)

Family Applications Before (2)

Country Status (11)

Families Citing this family (439)

Citations (7)

Family Cites Families (83)